Combo Treatment With Xalnesiran Shows Promise in Patients With Hep B
FRIDAY, Dec. 13, 2024 -- For patients with chronic hepatitis B virus (HBV) infection with virologic suppression with nucleoside or nucleotide analog (NA) therapy, xalnesiran plus an immunomodulator results in a substantial percentage of patients with hepatitis B surface antigen (HBsAg) loss, according to a study published in the Dec. 5 issue of the New England Journal of Medicine.
Jinlin Hou, M.D., from Nanfang Hospital in Guangzhou, China, and colleagues conducted a phase 2 multicenter, randomized, controlled trial involving adult patients with chronic HBV infection with virologic suppression with NA therapy to examine 48 weeks of treatment with xalnesiran 100 mg (group 1; 30 patients), xalnesiran 200 mg (group 2; 30 patients), xalnesiran 200 mg + ruzotolimod (group 3; 34 patients), xalnesiran 200 mg + pegylated interferon alfa-2a 180 µg (group 4; 30 patients), or NA alone (group 5; 35 patients). The primary efficacy end point was HBsAg loss at 24 weeks after the end of treatment.
The researchers found that a primary end point event occurred in 7, 3, 12, 23, and 0 percent of patients in groups 1, 2, 3, 4, and 5, respectively. At 24 weeks after the end of treatment, HBsAg seroconversion occurred in 3, 0, 3, 20, and 0 percent of participants, respectively. Only participants with a screening HBsAg level below 1,000 IU/mL had HBsAg loss with or without seroconversion.
"Despite the high percentages of participants with HBsAg loss that were observed in the immunomodulatory-therapy groups at the end of treatment, erosion of this response was observed during the follow-up period," the authors write.
The study was funded by F. Hoffmann-La Roche, which is developing xalnesiran.
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